CA2379441A1 - Stoma opening forming apparatus - Google Patents

Stoma opening forming apparatus Download PDF

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Publication number
CA2379441A1
CA2379441A1 CA002379441A CA2379441A CA2379441A1 CA 2379441 A1 CA2379441 A1 CA 2379441A1 CA 002379441 A CA002379441 A CA 002379441A CA 2379441 A CA2379441 A CA 2379441A CA 2379441 A1 CA2379441 A1 CA 2379441A1
Authority
CA
Canada
Prior art keywords
adjustment device
control
sensor
restriction
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002379441A
Other languages
French (fr)
Other versions
CA2379441C (en
Inventor
Peter Forsell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Obtech Medical AG
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2379441A1 publication Critical patent/CA2379441A1/en
Application granted granted Critical
Publication of CA2379441C publication Critical patent/CA2379441C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0053—Gastric bands remotely adjustable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/135—Tourniquets inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/135—Tourniquets inflatable
    • A61B17/1355—Automated control means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00539—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00734—Aspects not otherwise provided for battery operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/032—Automatic limiting or abutting means, e.g. for safety pressure limiting, e.g. hydrostatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Reproductive Health (AREA)
  • Prostheses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Formation And Processing Of Food Products (AREA)
  • Closing Of Containers (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Spectrometry And Color Measurement (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Beverage Vending Machines With Cups, And Gas Or Electricity Vending Machines (AREA)
  • Jellies, Jams, And Syrups (AREA)

Abstract

An apparatus for forming a stoma opening is used for the treatment of morbid obesity or heartburn and reflux disease. An implanted elongated restriction member (12) of the apparatus is formed in a substantially closed loop around a human's stomach or esophagus to define a restriction opening (16), whereby a corresponding stoma opening is formed in the stomach or esophagus. The size of the restriction opening is adjustable by an implanted adjustment device. A control device (22) is utilized to control the adjustment device, in order t o either reduce or enlarge the size of the restriction opening. Nausea in a treated obese human can be minimized or substantially eliminated as a result of the control device controlling the adjustment device to keep the restriction opening substantially fully open between meals (such as at night when the human is sleeping). A sensor (23), such as a pressure or position sensor, is surgically implanted in the human's body so that the sensor may either directly or indirectly sense a physical parameter of the human, such as the pressure in the stomach or the human's orientation with respect to the horizontal. If in response to sensing by the sensor it is determined by the control device that a significant change in the physical parameter has occurred, then the control device controls the adjustment device to either reduce or enlarge the size of the restriction opening.

Claims (47)

1. An apparatus for forming a stoma opening in the stomach or esophagus of a patient, the apparatus comprising:
an implantable elongated restriction member adapted to be formed into a substantially closed loop around the patient's stomach or esophagus, so that the loop defines a restriction opening, an implantable adjustment device for adjusting the restriction member in the loop to change the size of the restriction opening, and a control device for controlling the adjustment device to adjust the restriction member to change the size of the restriction opening.
2. An apparatus according to claim 1, further comprising an implantable sensor for sensing at least one physical parameter associated with the patient, wherein the control device is adapted to control the adjustment device in response to the sensor sensing a change in the physical parameter.
3. An apparatus according to claim 2, wherein the control device comprises an implantable internal control unit for directly controlling the adjustment device in response to signals from the sensor.
4. An apparatus according to claim 2, wherein the control device comprises an external control unit outside the patient's body for controlling the adjustment device in response to signals from the sensor.
5. An apparatus according to claim 4, wherein the external control unit directly controls the adjustment device in response to signals from the sensor.
6. An apparatus according to claim 4, wherein the external control unit stores information on the physical parameter sensed by the sensor and is manually operated to control the adjustment device based on the stored information.
7. An apparatus according to any of claims 2-6, further comprising at least one implantable sender for sending information on the physical parameter sensed by the sensor.
8. An apparatus according to any of claims 2-7, wherein the sensor comprises a pressure sensor for sensing as the physical parameter the pressure in the patient's stomach or esophagus.
9. An apparatus according to claim 8, wherein the pressure sensor is adapted to indirectly sense the pressure in the stomach by sensing the pressure exerted by the stomach against the restriction member.
10. An apparatus according to claim 8 or 9, wherein the control device is adapted to control the adjustment device to change the size of the restriction opening in response to the pressure sensor sensing a change in the pressure in the stomach or esophagus.
11. An apparatus according to claim 10, wherein the apparatus is intended for restricting the food intake of an obese patient, the control device being adapted to control the adjustment device to reduce the restriction opening in response to the pressure sensor sensing a pressure equal to or exceeding a predetermined value.
12. An apparatus according to claim 10 or 11, wherein the apparatus is intended for restricting the food intake of an obese patient, the control device being adapted to control the adjustment device to enlarge the restriction opening in response to the pressure sensor sensing a pressure below a predetermined value.
13. An apparatus according to any of claims 10-12, wherein the apparatus is intended for restricting the food intake of an obese patient, the control device being adapted to control the adjustment device to enlarge the restriction opening in response to the pressure sensor sensing a pressure equal to or exceeding an excessively high value.
14. An apparatus according to claim 10, wherein the apparatus is intended for treating heartburn and reflux disease, the control device being adapted to control the adjustment device to enlarge the restriction opening in response to the pressure sensor sensing a pressure equal to or exceeding a predetermined value.
15. An apparatus according to claim 10 or 14, wherein the apparatus is intended for treating heartburn and reflux disease, the control device being adapted to control the adjustment device to reduce or close the restriction opening in response to the pressure sensor sensing a pressure below a predetermined value.
16. An apparatus according to any of claims 10,14 and 15, wherein the apparatus is intended for treating heartburn and reflux disease, the control device being adapted to control the adjustment device to enlarge or fully open the restriction opening in response to the pressure sensor sensing a pressure equal to or exceeding an excessively high value, to avoid injurious high pressures in the stomach or esophagus.
17. An apparatus according to any of claims 2-7, wherein the sensor comprises a position sensor for sensing as the physical parameter the orientation of the patient with respect to the horizontal.
18. An apparatus according to any of claims 8-16, further comprising a position sensor for sensing the orientation of the patient with respect to the horizontal.
19. An apparatus according to claim 17 or 18, wherein the apparatus is intended for restricting the food intake of an obese patient, the control device being adapted to control the adjustment device to increase the restriction opening in response to the position sensor sensing that the patient has assumed a substantially horizontal orientation.
20. An apparatus according to claim 17 or 18, wherein the apparatus is intended for treating heartburn and reflux disease, the control device being adapted to control the adjustment device to close the restriction opening in response to the position sensor sensing that the patient has assumed a substantially horizontal orientation.
21. An apparatus according to claim 1, wherein the control device is adapted to control the adjustment device in response to the time of the day.
22. An apparatus according to claim 21, wherein the control device comprises a clock mechanism used for controlling the adjustment device to adjust the restriction member to keep the restriction opening at different sizes during different time periods of the day.
23. An apparatus according to any of claims 2-7, wherein the control device comprises a clock mechanism used for controlling the adjustment device to adjust the restriction member to keep the restriction opening at different sizes during different time periods of the day, provided that the physical parameter sensed by the sensor does not override the clock mechanism.
24. An apparatus according to any of claims 1-23, wherein the control device comprises an implantable internal control unit, and further comprising a wireless remote control adapted to set control parameters of the internal control unit from outside the patient without mechanically penetrating the patient, when the internal control unit is implanted in the patient.
25. An apparatus according to claim 2 and 24, wherein at least one of the control parameters, which is settable by the wireless control, is the physical parameter.
26. An apparatus according to claim 24 or 25, wherein the internal control unit includes a clock mechanism used for controlling the adjustment device to adjust the restriction member to keep the restriction opening at different sizes during different time periods of the day.
27. An apparatus according to claim 26, wherein the wireless remote control is adapted to set the clock mechanism.
28. An apparatus according to claim 1, wherein the control device comprises a wireless remote control.
29. An apparatus according to claim 28, wherein the wireless remote control comprises a signal transmitter, an implantable signal receiver, and an implantable energizer unit for transforming wireless energy from the signals, as they are transmitted from the signal transmitter to the signal receiver, into energy different than the wireless energy for energizing the adjustment device.
30. An apparatus according to claims 2 and 29, wherein the energy transformed from the wireless energy is used for energizing the implantable sensor.
31. An apparatus according to claim 1, wherein the adjustment device comprises an expandable cavity in the restriction member, the size of the restriction opening being reduced upon expansion of the cavity and increased upon contraction of the cavity, and a reservoir for hydraulic fluid, the adjustment device being adapted to distribute hydraulic fluid from the reservoir to expand the cavity, and to distribute hydraulic fluid from the cavity to the reservoir to contract the cavity, to thereby change the size of the restriction opening.
32. An apparatus according to claim 31, wherein the reservoir is attached to the restriction member.
33. An apparatus according to claim 31, wherein the reservoir is fixed to the restriction member.
34. An apparatus according to claim 31, wherein the reservoir is integrated with the restriction member.
35. An apparatus according to any of claims 31-34, wherein the adjustment device comprises a pump for pumping fluid between the cavity and the reservoir.
36. An apparatus according to claim 35, wherein the pump is attached to the restriction member.
37. An apparatus according to claim 35, wherein the pump is fixed to the restriction member.
38. An apparatus according to claim 35, wherein the reservoir, pump and restriction member form a single piece.
39. An apparatus according to claim 35, wherein the reservoir, pump, sensor and restriction member form a single piece.
40. An apparatus according to claim 35, wherein the pump is adapted to be subcutaneously implanted in the patient remote from the restriction member.
41. An apparatus according to claim 1-30, wherein the adjustment device is adapted to mechanically adjust the restriction member.
42. An apparatus according to any of claims 1-41, further comprising an implantable battery for energizing the adjustment device.
43. An apparatus according to any of claims 1-41, further comprising an implantable accumulator for energizing the adjustment device.
44. An apparatus according to claim 43, wherein the accumulator comprises a capacitor.
45. An apparatus according to any of claims 2-20,25 and 30, further comprising an implantable battery for energizing the sensor.
46. An apparatus according to any of claims 2-20,25 and 30, further comprising an implantable accumulator for energizing the sensor.
47. An apparatus according to claim 46, wherein the accumulator comprises a capacitor.
CA002379441A 1999-08-12 2000-08-01 Stoma opening forming apparatus Expired - Lifetime CA2379441C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US37322499A 1999-08-12 1999-08-12
US09/373,224 1999-08-12
PCT/SE2000/001531 WO2001012078A1 (en) 1999-08-12 2000-08-01 Stoma opening forming apparatus

Publications (2)

Publication Number Publication Date
CA2379441A1 true CA2379441A1 (en) 2001-02-22
CA2379441C CA2379441C (en) 2009-11-24

Family

ID=23471500

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002379441A Expired - Lifetime CA2379441C (en) 1999-08-12 2000-08-01 Stoma opening forming apparatus

Country Status (15)

Country Link
US (1) US20010011543A1 (en)
EP (1) EP1211988B1 (en)
CN (1) CN1250168C (en)
AT (1) ATE457686T1 (en)
AU (1) AU769270B2 (en)
BR (1) BR0012999A (en)
CA (1) CA2379441C (en)
DE (1) DE60043853D1 (en)
ES (1) ES2338208T3 (en)
IL (2) IL147961A0 (en)
MX (1) MXPA02001217A (en)
NO (1) NO20020679L (en)
NZ (1) NZ516962A (en)
WO (1) WO2001012078A1 (en)
ZA (1) ZA200201145B (en)

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